# Is LL-37 legal in Australia? Poisons Standard, TGA, FDA and WADA records Updated 2026-10-16. The records read on 16 October 2026 give no simple yes-or-no answer about LL-37. The October 2026 Poisons Standard (F2026L01327) has no LL-37 or cathelicidin entry in its text. The TGA peptide advisory does not name LL-37. The FDA lists cathelicidin LL-37 among withdrawn nominations with safety concerns. The WADA 2026 Prohibited List does not name LL-37. Each record answers its own question. | | | | --- | --- | | Poisons Standard | No LL-37 or cathelicidin occurrence in the text of the [October 2026 instrument, F2026L01327](https://www.legislation.gov.au/F2026L01327/latest/text), searched 16 October 2026; group headings and derivative provisions not assessed | | TGA | Peptide advisory names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples and does not name LL-37 ([TGA advisory](https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products), read 16 October 2026) | | ARTG | Not searched for this page | | FDA | Cathelicidin LL-37 in the table of nominated-but-withdrawn bulk drug substances ([FDA page](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks), content current as of 22 April 2026) | | WADA 2026 Prohibited List | LL-37 not named in the List text; in force from 1 January 2026 ([WADA 2026 List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf)) | | Records checked | 16 October 2026 | Medicines law, scheduling rules and sport rules each look at the same molecule through a different window. A name missing from one document does not mean that another document gives permission. This page belongs to [the LL-37 hub](/learn/ll-37). It lists each record that mentions LL-37 or the rules around it, what the record says, and when it was read. For the molecule itself, see [what LL-37 is](/learn/ll-37/what-is-ll-37). This page gives no legal advice. ## Is LL-37 in the Australian Poisons Standard? A text search of the October 2026 Poisons Standard, run on 16 October 2026, found no LL-37, LL37 or cathelicidin. Its full name is the Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, F2026L01327. The Poisons Standard is the national list that sorts medicines and poisons into classes. For example, Schedule 4 covers prescription-only medicines. A missing name is not permission. The document also has group headings, such as one for antibiotic substances, and rules that stretch entries to derivatives, meaning related substances. This page has not assessed whether any of them reaches LL-37. A lawyer would need to. The search covered the main text of the document taken from the Federal Register of Legislation. It finds named entries and nothing more. [What Schedule 4 and Appendix D mean](/learn/peptides-and-australian-law/what-schedule-4-and-appendix-d-mean) explains the entries that do exist for other peptides. ## What has the TGA said about peptide products like LL-37? The TGA is Australia's medicines regulator. It treats peptide products as therapeutic goods under the Therapeutic Goods Act 1989. It says unapproved peptide products are goods that are not included in the Australian Register of Therapeutic Goods (ARTG). The ARTG is the national list of approved medicines and devices. The TGA advisory says these products have not been assessed by the TGA for safety, quality or effectiveness. It names BPC-157, GHK-Cu, TB-500, retatrutide and CJC-1295 as examples. It does not name LL-37. This hub read the advisory on 16 October 2026. Whether a given LL-37 product is on the ARTG is answered by [the TGA's own register search](https://www.tga.gov.au/resources/artg). This page did not run that search. Nothing here says that any LL-37 product is or is not registered. ## What does the FDA say about LL-37? The FDA lists cathelicidin LL-37 on its page of bulk drug substances that may present significant safety risks. It sits in the table of substances that were nominated and then withdrawn. That table lists substances once in category 2 of the FDA's interim policies, which the people who nominated them later withdrew. The FDA says compounded drugs containing LL-37 may pose an immunogenicity risk for certain routes of administration, and that it lacks enough safety information. A withdrawn nomination is separate from medicine approval. The table records nomination status and safety concerns. It does not establish the approval status of every LL-37 preparation. Compounding means a pharmacy makes a customised medicine. The page content was current as of 22 April 2026, and this hub read it on 16 October 2026. The same page lists nonclinical findings, covered with the other safety records on [the side effects page](/learn/ll-37/ll-37-side-effects). The page does not say that the FDA has approved any medicine containing LL-37. This page did not search an FDA medicine-approval database. ## Is LL-37 banned in sport? The WADA 2026 Prohibited List does not name LL-37 or cathelicidin anywhere in its text. WADA is the World Anti-Doping Agency. Its 2026 List has been in force since 1 January 2026, and this hub searched it on 16 October 2026. Section S0 of the List prohibits at all times any pharmacological (drug-like) substance that no later section covers and that has no current approval from any government health regulator for human therapeutic use. This page did not decide whether LL-37 falls under that wording, or under a group entry in a later section. An athlete should ask their anti-doping organisation, not rely on this page. WADA publishes a new List each year, so a later List may differ from the 2026 text. Sport rules are separate from the Poisons Standard and from TGA approval. A name missing from the List raises a question about definitions; it is not a clearance. ## What do these records not settle? These records do not settle whether any person may lawfully supply, import or possess LL-37 in Australia. A text search of the Poisons Standard finds named entries only. The document also uses group headings and rules for derivatives. The TGA advisory talks about unapproved peptide products as a whole group, not one by one. The FDA page is about US pharmacy compounding. WADA rules cover sport, not general law. This page did not read state and territory laws. Each record answers a different question about regulation, so no single record gives the full answer. For the wider Australian picture, [the guide to peptides and Australian law](/learn/peptides-and-australian-law) sets out the layers. ![Diagram of one small molecule in the centre seen through four separate window frames, labelled Poisons Standard, TGA, FDA and WADA.](/assets/content/edu-four-records-four-windows.png) Four records checked on 16 October 2026 each answer a different question about LL-37: the Poisons Standard F2026L01327, the TGA peptide advisory, the FDA bulk substances safety page and the WADA 2026 Prohibited List. Sources: Federal Register of Legislation, TGA, FDA, WADA. ## Comparison Four records checked for LL-37, each read on 16 October 2026. 'What it does not say' lists what the record leaves open. Records only; this is not legal advice. | Body | Record | What it says about LL-37 | What it does not say | | --- | --- | --- | --- | | Poisons Standard (Commonwealth) | [F2026L01327](https://www.legislation.gov.au/F2026L01327/latest/text), October 2026 | No LL-37 or cathelicidin occurrence in the instrument text | That LL-37 is outside group headings or derivative provisions | | TGA | [Peptide advisory](https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts/understanding-your-responsibilities-when-importing-compounding-and-supplying-unapproved-peptide-products), read 16 October 2026 | Treats unapproved peptide products as a class; LL-37 not named | Whether any LL-37 product is on the ARTG | | FDA | [Safety-risk page](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks), content current as of 22 April 2026 | Lists cathelicidin LL-37 among withdrawn nominations; names immunogenicity and impurity concerns; lacks sufficient safety information | An approval, a warning letter or an enforcement action | | WADA | [2026 Prohibited List](https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf) | LL-37 not named; S0 wording describes unapproved substances not addressed elsewhere | Whether S0 or a class entry reaches LL-37 | ## Frequently asked questions ### Is LL-37 on the Poisons Standard? No LL-37 or cathelicidin entry was found in the text of the October 2026 instrument, F2026L01327, on 16 October 2026. That is a finding about named entries only. Group headings and derivative provisions were not assessed. ### Is LL-37 approved by the TGA? This page did not establish whether an LL-37 medicine is approved, because the ARTG was not searched. The TGA advisory on unapproved peptide products does not name LL-37. [The TGA's ARTG search](https://www.tga.gov.au/resources/artg) answers the question for a named product. ### Has the FDA approved LL-37? This page did not search an FDA medicine-approval database, so approval status is not established here. The FDA lists cathelicidin LL-37 among withdrawn nominations and says it lacks sufficient safety information. ### Is LL-37 on the WADA Prohibited List? The WADA 2026 Prohibited List does not name LL-37 in its text. Section S0 can apply to an unapproved substance that no later section addresses. Athletes should ask their anti-doping organisation about their own case. ## Citations - Mahlapuu M, Sidorowicz A, Mikosinski J, et al.. Wound Repair and Regeneration. 2021;29(6):938-950. DOI: 10.1111/wrr.12977 - Grönberg A, Mahlapuu M, Ståhle M, Whately-Smith C, Rollman O. Wound Repair and Regeneration. 2014;22(5):613-621. DOI: 10.1111/wrr.12211 --- Canonical page: https://www.formlaboratories.com/learn/ll-37/is-ll-37-legal-in-australia Form Laboratories - Perth-based research-use-only peptide supplier, shipping Australia-wide. - Site guide for agents: https://www.formlaboratories.com/llms.txt - Sitemap: https://www.formlaboratories.com/sitemap.xml - Full catalogue: https://www.formlaboratories.com/shop - Contact: hello@formlaboratories.com All materials are supplied for laboratory research use only - not for human or veterinary use, and nothing on this site is medical advice.